Central Venous Catheter Colonisation Among Critically Ill Patients in Intensive Care Units

Sepsis Clinical Trial

Official title:

Central Venous Catheter Colonisation: Prevalence and Associated Factors Among Critically Ill Patients Admitted to Ugandan Intensive Care Units

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03270774
• Other study ID #: CVC Study
• Status: Completed
• Phase: N/A
• First received: August 30, 2017
• Last updated: August 31, 2017
• Start date: April 19, 2016
• Est. completion date: April 19, 2017

Study information

• Verified date: August 2017
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background: Central Venous catheter insertion technique and indwelling time are major risk factors for CVC colonisation. Colonisation occurs through microbial migration and biofilm formation along the catheter insertion tract. This study set out to determine the prevalence and associated factors for central venous catheter colonisation among critically ill patient. No data exists in this clinical setting addressing this topic.

Methods: The study population included 100 participants with central venous catheters in situ for at least 24 hours. Catheter tip (distal 5-cm segment) and blood cultures (10mls peripheral blood) were obtained at the time of catheter removal.

Description:

Introduction : Central venous catheter (CVC) insertion technique and time spent in situ (dwell period) are major risk factors for CVC colonisation among patients admitted to intensive care units (ICU) worldwide. Normal skin flora colonizes CVCs early in their dwell period (< 7-10 days) causing variable occurrence of infections in all categories of patients. Uganda has no data on CVC colonisation and with increasing use there is concern of CVC colonisation and its consequences. This study was done to determine the prevalence and associated factors of CVC colonization among patients in general ICUs.

Methodology: This was prospective cohort study. Critically ill patients with CVCs in situ from four general ICUs were consecutively enrolled into the study. Data on socio-demographic, clinical characteristics (diagnosis, comorbidities) and CVC insertion (site, technique, experience) was collected using a standardised questionnaire until a sample size of 100 was achieved. At the time of CVC removal, the CVC tip (distal 5cm segment) was aseptically obtained and cultured for microorganisms using the semi-quantitative method. A blood culture sample (10mls) was also collected from a peripheral site at the same time. Data was double entered into EPIDATA version 3.1.5 and exported to STATA version 12.0 for analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 19, 2017
• Est. primary completion date: April 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients of all age groups were included in this study

• All critically ill patients admitted to the ICU with Central Venous Catheters in situ

• Written informed consent/assent

• Waiver of consent for unconscious patients with no attendant/valid surrogate respondent to provide the required information

Exclusion Criteria:

•Patients who were already on treatment for CVC-related infectious complications.

Related Conditions & MeSH terms

• Acute Liver Failure
• Brain Injuries
• Coma
• Craniocerebral Trauma
• Critical Illness
• Diabetic Ketoacidotic Hyperglycaemic Coma
• Head Injury
• Heart Arrest
• Hypoxia, Brain
• Hypoxic Brain Damage
• Liver Failure
• Liver Failure, Acute
• Post-cardiac Surgery
• Post-Cardiorespiratory Arrest Coma
• Sepsis
• Septic Shock
• Shock, Septic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Makerere University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of central venous catheter colonisation	Of the patients that had central venous catheter inserted, how many of them developed central venous catheter colonisation	up to 14 days
Secondary	Prevalence of Central venous catheter associated bloodstream infections	Of the patients that developed central venous catheter colonisation, how many of them developed associated bloodstream infection	Up to 48 hours after removal of central venous catheter
Secondary	Factors associated with central venous catheter colonisation	Factors that have a significant p-value < 0.5 of association with central venous catheter colonisation	up to 14 days